A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

October 4, 2022

Primary Completion Date

November 29, 2024

Study Completion Date

November 29, 2024

Conditions
Hepatitis B
Interventions
COMBINATION_PRODUCT

GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide

Three doses of GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide administered intramuscularly in the non-dominant arm, one each at Day 1, Day 31 and Day 181.

BIOLOGICAL

GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system

Two doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

BIOLOGICAL

GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system

Two doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

BIOLOGICAL

GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system formulation 1

Two doses of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system formulation 1 administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

BIOLOGICAL

GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2

Two doses of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2 administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

Trial Locations (5)

3000

GSK Investigational Site, Leuven

22143

GSK Investigational Site, Hamburg

39120

GSK Investigational Site, Magdeburg

51069

GSK Investigational Site, Cologne

CB2 2GG

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT05561673 - A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years | Biotech Hunter | Biotech Hunter